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Project Quality Assurance Manager(M/F/D)
Tasks:
Project Quality Assurance Representative related to qualification, validation and transfer activities for artworks and products in cooperation with Engineering department, Qualification Department, Production and the Laboratories for:
Building and (Clean)rooms
Utilities
Multiple production equipment
Manufacturing Processes
Analytical and microbiological method validations
Computer system validation
Review, creation, assessment, and completion as Project Quality Representative in alignment with site QA of project related documentation against current GMP-requirements such as (but not limited to):
Design Qualification (URS, FRS, FAT, SAT) and Commissioning
Risk Assessments (e.g. FMEA)
Installation-, Operational- and Performance Qualification
Process and Method validations
Documents for regulatory purposes
Assessments
PQR
CCS
Change controls
Deviations
Complaints
CAPA
Apply professional interdisciplinary project work consulting the team with Engineering department, Qualification Department, Production, EHS and the Laboratories in questions regarding GMP-compliant solutions
Perform root cause analyses and troubleshooting activities together with the project team in case of deviations from Quality Assurance Perspective
Contact to the overall project leaders in different departments and within the global project team to share input from Quality Assurance Perspective
Qualification:
Minimum 3 years professional experience in pharmaceutical Quality Assurance
Exceptional knowledge about GMP-requirements and pharmacopoeia (Ph. Eur., USP)
Exceptional knowledge in the areas of qualification and validation of building, utilities, equipment, manufacturing processes and analytical and microbiological methods (knowledge in computer system validation preferred)
Project management knowledge, leadership capabilities with respect to quality topics
Experience with implementation of new pharmaceutical products or transfers preferred
Proficient communication skills in an English-speaking project environment, good German language skills in spoken and written
Requirements:
Start: 01.06.2026
Duration: 6 months
Capacity: 5 days per week
Location: Lower Saxony, Germany
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